The FDA has placed a partial clinical hold on the TELLOMAK trial (NCT03902184), which is evaluating the efficacy and safety of lacutamab (IPH4102) in patients with advanced T-cell lymphoma.1
Enrollment of new patients has been suspended in the study, except for in Italy where the trial has been suspended.
Innate Pharma SA, the developer of lacutamab, stated in a press release that it has been in discussions with regulatory authorities regarding Good Manufacturing Practice (GMP) deficiencies at their manufacturing subcontractor site, which manages the fill and finish operations of the drug’s clinical trials. Innate Pharma’s subcontractor, Rentschler Fill Solutions GmbH (RFS), unilaterally withdrew its Certificate of Conformity of batches it produced, including the batch of lacutamab that was currently used in the TELLOMAK study; RFS also filed for bankruptcy.
“The Company’s utmost priority is to ensure patient safety,” Innate Pharma stated in a press release. “An extensive internal and third-party analysis concluded that there was no evidence that the integrity of the product was questioned.”
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